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Medication Summary

Antibiotics are the mainstay of therapy for bacterial vaginosis. Medications include metronidazole (Flagyl), clindamycin (Cleocin) oral or vaginal suppositories, and metronidazole vaginal gel (MetroGel-Vaginal). Metronidazole and clindamycin are the preferred medications used to treat Gardnerella infections. See Medication for specific information on these medications.

In September 2017, the FDA approved the first single-dose oral treatment secnidazole (Solosec, Symbiomix Therapeutics) for women with bacterial vaginosis.^[22] Approval was based on two randomized, placebo-controlled studies which evaluated the efficacy of secnidazole in treatment of bacterial vaginosis. Efficacy was assessed by clinical outcomes evaluated 21-30 days following a single dose of secnidazole. A clinical responder was defined as having "normal" vaginal discharge, negative "whiff" test, and clue cells < 20%; additional endpoints included Nugent score cure and therapeutic outcome.

In both trials, a statistically significantly greater percentage of patients experienced clinical response (Trial 1: 67.7%; Trial 2: 53.3%), Nugent score cure (Trial 1: 40.3%; Trial 2: 43.9%), and therapeutic response (Trial 1: 40.3%; Trial 2: 34.6%) at 21-30 days following a single dose of Solosec compared to placebo.^{[23, 24]}

A double-blind, randomized controlled trial by Subtil et al that included 5630 pregnant women with bacterial vaginosis reported that systematic screening and subsequent treatment for bacterial vaginosis in women with low-risk pregnancies showed no evidence of risk reduction of late miscarriage or spontaneous very preterm birth.^[25]

Class Summary

Therapy must be comprehensive and cover all likely pathogens in the context of this clinical setting.

Clindamycin (Cleocin)

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Bacteriostatic antibiotic used against gram-positive aerobes and gram-positive and gram-negative anaerobes. Inhibits bacterial growth, possibly by blocking dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest. Available as capsule and 2% vaginal cream formulation.

Metronidazole (Flagyl)

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Bactericidal antibiotic enters bacterial cell and is reduced by electron transport proteins. Free radicals are formed, which react with intracellular components and/or DNA and result in subsequent cell death. Antimicrobial spectrum includes many gram-positive and gram-negative anaerobes and protozoal parasites.

Metronidazole (MetroGel-Vaginal)

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Bactericidal antibiotic enters the bacterial cell and is reduced by electron transport proteins. Free radicals are formed, which react with intracellular components and/or DNA and result in subsequent cell death. Antimicrobial spectrum includes many gram-positive and gram-negative anaerobes and protozoal parasites.

Secnidazole (Solosec)

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Secnidazole is a nitroimidazole derivative; 5-nitroimidazoles enters the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions; it is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates. It is indicated for bacterial vaginosis in females aged 12 years and older.

Follow-up

Brocklehurst P, Gordon A, Heatley E, Milan SJ. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database Syst Rev. 2013 Jan 31. 1:CD000262. [QxMD MEDLINE Link].
Amsel R, Totten PA, Spiegel CA, Chen KC, Eschenbach D, Holmes KK. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983 Jan. 74(1):14-22. [QxMD MEDLINE Link].
Schuyler JA, Mordechai E, Adelson ME, Sobel JD, Gygax SE, Hilbert DW. Identification of intrinsically metronidazole-resistant clades of Gardnerella vaginalis. Diagn Microbiol Infect Dis. 2015 Oct 8. [QxMD MEDLINE Link].
Tabrizi SN, Fairley CK, Bradshaw CS, Garland SM. Prevalence of Gardnerella vaginalis and Atopobium vaginae in virginal women. Sex Transm Dis. 2006 Nov. 33(11):663-5. [QxMD MEDLINE Link].
Patterson JL, Girerd PH, Karjane NW, Jefferson KK. Effect of biofilm phenotype on resistance of Gardnerella vaginalis to hydrogen peroxide and lactic acid. Am J Obstet Gynecol. 2007 Aug. 197(2):170.e1-7. [QxMD MEDLINE Link]. [Full Text].
Fredricks DN, Fiedler TL, Thomas KK, Oakley BB, Marrazzo JM. Targeted PCR for detection of vaginal bacteria associated with bacterial vaginosis. J Clin Microbiol. 2007 Oct. 45(10):3270-6. [QxMD MEDLINE Link]. [Full Text].
Meriwether KV, Rogers RG, Craig E, Peterson SD, Gutman RE, Iglesia CB. The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2015 Nov. 213 (5):729.e1-9. [QxMD MEDLINE Link].
Harrison P. Bacterial Vaginosis Raises HIV Risk, Lowers Tenofovir Level. Medscape Medical News. Available at http://www.medscape.com/viewarticle/866342. July 19, 2016; Accessed: December 7, 2016.
Payne SC, Cromer PR, Stanek MK, Palmer AA. Evidence of African-American women's frustrations with chronic recurrent bacterial vaginosis. J Am Acad Nurse Pract. 2010 Feb. 22(2):101-8. [QxMD MEDLINE Link].
Marrazzo JM, Fiedler TL, Srinivasan S, et al. Extravaginal reservoirs of vaginal bacteria as risk factors for incident bacterial vaginosis. J Infect Dis. 2012 May 15. 205(10):1580-8. [QxMD MEDLINE Link]. [Full Text].
Coughlin G, Secor M. Bacterial vaginosis: update on evidence-based care. Adv Nurse Pract. 2010 Jan. 18(1):41-4, 53. [QxMD MEDLINE Link].
Alcaide ML, Chisembele M, Malupande E, Arheart K, Fischl M, Jones DL. A cross-sectional study of bacterial vaginosis, intravaginal practices and HIV genital shedding; implications for HIV transmission and women's health. BMJ Open. 2015 Nov 9. 5 (11):e009036. [QxMD MEDLINE Link].
Thurman AR, Kimble T, Herold B, et al. Bacterial Vaginosis and Subclinical Markers of Genital Tract Inflammation and Mucosal Immunity. AIDS Res Hum Retroviruses. 2015 Nov. 31 (11):1139-52. [QxMD MEDLINE Link].
Schwiertz A, Taras D, Rusch K, Rusch V. Throwing the dice for the diagnosis of vaginal complaints?. Ann Clin Microbiol Antimicrob. 2006 Feb 17. 5:4. [QxMD MEDLINE Link]. [Full Text].
Mohanty S, Sood S, Kapil A, Mittal S. Interobserver variation in the interpretation of Nugent scoring method for diagnosis of bacterial vaginosis. Indian J Med Res. 2010 Jan. 131:88-91. [QxMD MEDLINE Link].
West B, Morison L, Schim van der Loeff M, et al. Evaluation of a new rapid diagnostic kit (FemExam) for bacterial vaginosis in patients with vaginal discharge syndrome in The Gambia. Sex Transm Dis. 2003 Jun. 30(6):483-9. [QxMD MEDLINE Link].
Reid G, Burton J, Hammond JA, Bruce AW. Nucleic acid-based diagnosis of bacterial vaginosis and improved management using probiotic lactobacilli. J Med Food. 2004 Summer. 7(2):223-8. [QxMD MEDLINE Link].
Masson L, Arnold KB, Little F, et ak. Inflammatory cytokine biomarkers to identify women with asymptomatic sexually transmitted infections and bacterial vaginosis who are at high risk of HIV infection. Sex Transm Infect. 2015 Oct 28. [QxMD MEDLINE Link].
Abramovici A, Lobashevsky E, Cliver SP, Edwards RK, Hauth JC, Biggio JR. Quantitative polymerase chain reaction to assess response to treatment of bacterial vaginosis and risk of preterm birth. Am J Perinatol. 2015 Oct. 32 (12):1119-25. [QxMD MEDLINE Link].
Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010 Aug. 203(2):120.e1-6. [QxMD MEDLINE Link].
[Guideline] Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23. 70 (4):1-187. [QxMD MEDLINE Link]. [Full Text].
SOLOSEC: Prescribing Information. Symbiomix Therapeutics LLC. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf. 2017; Accessed: September 20, 2017.
Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis. Am J Obstet Gynecol. 2017 Sep 1. [QxMD MEDLINE Link]. [Full Text].
Bohbot JM, Vicaut E, Fagnen D, Brauman M. Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol. 2010. [QxMD MEDLINE Link]. [Full Text].
Subtil D, Brabant G, Tilloy E, et al. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Oct 12. [QxMD MEDLINE Link].
De Backer E, Verhelst R, Verstraelen H, et al. Antibiotic susceptibility of Atopobium vaginae. BMC Infect Dis. 2006 Mar 16. 6:51. [QxMD MEDLINE Link]. [Full Text].
Amaya-Guio J, Viveros-Carreño DA, Sierra-Barrios EM, Martinez-Velasquez MY, Grillo-Ardila CF. Antibiotic treatment for the sexual partners of women with bacterial vaginosis. Cochrane Database Syst Rev. 2016 Oct 1. 10:CD011701. [QxMD MEDLINE Link].

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Author

Philippe H Girerd, MD Associate Professor, Department of Obstetrics and Gynecology, Virginia Commonwealth University, Medical College of Virginia

Philippe H Girerd, MD is a member of the following medical societies: American College of Obstetricians and Gynecologists, Association of Professors of Gynecology and Obstetrics, Medical Society of Virginia, AAGL

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

A David Barnes, MD, MPH, PhD, FACOG Consulting Staff, Department of Obstetrics and Gynecology, Mammoth Hospital (Mammoth Lakes, CA), Pioneer Valley Hospital (Salt Lake City, UT), Warren General Hospital (Warren, PA), and Mountain West Hospital (Tooele, UT)

A David Barnes, MD, MPH, PhD, FACOG is a member of the following medical societies: American College of Forensic Examiners Institute, American College of Obstetricians and Gynecologists, The Society of Federal Health Professionals (AMSUS), American Medical Association, Utah Medical Association

Disclosure: Nothing to disclose.

Chief Editor

Michel E Rivlin, MD Former Professor, Department of Obstetrics and Gynecology, University of Mississippi School of Medicine

Michel E Rivlin, MD is a member of the following medical societies: American College of Obstetricians and Gynecologists, American Medical Association, Mississippi State Medical Association, Royal College of Surgeons of Edinburgh, Royal College of Obstetricians and Gynaecologists

Disclosure: Nothing to disclose.

Additional Contributors

Thomas Michael Price, MD Professor Emeritus, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Former Director of Reproductive Endocrinology and Infertility Fellowship Program, Duke University Medical Center

Thomas Michael Price, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Obstetricians and Gynecologists, American Society for Reproductive Medicine, Phi Beta Kappa, Society for Reproductive Endocrinology and Infertility, Society for Reproductive Investigation

Disclosure: Received research grant from: Insigtec Inc<br/>Received consulting fee from Clinical Advisors Group for consulting; Received consulting fee from MEDA Corp Consulting for consulting; Received consulting fee from Gerson Lehrman Group Advisor for consulting; Received honoraria from ABOG for board membership.

Acknowledgements

Burke A Cunha, MD Professor of Medicine, State University of New York School of Medicine at Stony Brook; Chief, Infectious Disease Division, Winthrop-University Hospital

Burke A Cunha, MD is a member of the following medical societies: American College of Chest Physicians, American College of Physicians, and Infectious Diseases Society of America

Disclosure: Nothing to disclose.

Diana Curran, MD, FACOG Assistant Professor, Residency Program Director, Department of Obstetrics and Gynecology, University of Michigan Health Systems

Diana Curran, MD, FACOG is a member of the following medical societies: American College of Obstetricians and Gynecologists, American Medical Association, and Central Association of Obstetricians and Gynecologists

Disclosure: Nothing to disclose.

Eric A Hansen, DO, Fellow, Clinical Instructor, Department of Internal Medicine, Division of Infectious Diseases, Winthrop-University Hospital, State University of New York at Stony Brook

Disclosure: Nothing to disclose.

Clinical Elements		Bacterial Vaginosis	Trichomoniasis	Vaginal Candidiasis
Symptoms	Vaginal odor	+	+/-	-
	Vaginal discharge	Thin, gray, homogenous	Green-yellow	White, curdlike
	Vulvar irritation	+/-	+	+
	Dyspareunia	-	+	-
Signs	Vulvar erythema	-	+/-	+/-
	Bubbles in vaginal fluid	+	+/-	-
	Strawberry cervix	-	+/-	-
Microscopy	Saline wet mount
	Clue cells	+	-	-
	Motile protozoa	-	+	-
	KOH test
	Pseudohyphae	-	-	+
	Whiff test	+	+/-	-
	pH	>4.5	>4.5	< 4.5

Bacterial Vaginosis Medication

Medication Summary

Antibiotics

Class Summary

Clindamycin (Cleocin)

Clindamycin (Cleocin)

Metronidazole (Flagyl)

Metronidazole (Flagyl)

Metronidazole (MetroGel-Vaginal)

Metronidazole (MetroGel-Vaginal)

Secnidazole (Solosec)

Secnidazole (Solosec)

References

Tables

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